NCT07566949 The Finnish Uterine Prolapse Surgery Trial (The Fin-UP Trial)
| NCT ID | NCT07566949 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tampere University Hospital |
| Condition | Uterine Prolapse |
| Study Type | INTERVENTIONAL |
| Enrollment | 426 participants |
| Start Date | 2026-05 |
| Primary Completion | 2033-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 426 participants in total. It began in 2026-05 with a primary completion date of 2033-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to compare the Manchester procedure and vaginal hysterectomy in treating patients with symptomatic uterine prolapse. The main question it aims to answer is: • What is the difference in the success rates at the the two year follow-up Participants will: * be randomized in either the Manchester procedure or vaginal hysterectomy group and operated as such * visit the clinic at 2 and 5 years after the operation * fill in questionnaires at 1, 2, 5 and 10 years after the operation
Eligibility Criteria
Inclusion Criteria: * Fit for elective vaginal surgery according to standard preoperative assessment * Women aged over 18 years * No previous POP surgery * Symptomatic POP stage 2 or higher, with uterine descent of at least stage 2 (POP-Q point C ≥ minus 1) and with POP-Q point D ≤ minus 1. Patients with concurrent anterior or posterior compartment defects will be included. Exclusion Criteria: * Pregnancy or future plans of pregnancy * Active malignancy of any kind * Contraindications for uterine preservation, i.e. suspected cervical or uterine malignancy, abnormal cervical cytology, abnormal uterine bleeding, a history of endometrial hyperplasia with atypia, or a known hereditary cancer syndrome involving the uterus (e.g., Lynch syndrome). All patients will undergo a clinical examination and ultrasound assessment prior to recruitment. If clinically indicated, a Pap-smear and/or endometrial biopsy will be performed prior to inclusion. * Contraindication to vaginal hysterectomy (e.g. extensive intra-abdominal adhesions) * Patient's preference for uterine removal or preservation * Planned concomitant incontinence procedure * Inability to speak Finnish or Swedish, understand the purpose of the study, or commit to follow-up
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07566949 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 100 Years, studying Uterine Prolapse. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07566949 currently recruiting?
Yes, NCT07566949 is actively recruiting participants. Contact the research team at paivi.karjalainen@hyvaks.fi for enrollment information.
Where is the NCT07566949 trial being conducted?
This trial is being conducted at Helsinki, Finland, Jyväskylä, Finland, Kuopio, Finland, Oulu, Finland and 2 additional locations.
Who is sponsoring the NCT07566949 clinical trial?
NCT07566949 is sponsored by Tampere University Hospital. The trial plans to enroll 426 participants.